The invention relates to a liquid, bismuth containing medicinal product, to a process for producing it and its use. More particularly the invention relates to a packaged product containing a liquid, citric acid chelated, bismuth containing composition.
Liquid products containing bismuth salts are known, as described in German patent application DE-OS 19 02 168 or European Patent Application EP-A 217 440. The pharmaceutical bismuth products known in the form of solutions or suspensions are available in open systems, e.g. in bottles and are unstable, so that special additives or weight ratios are required. Thus, colloidal, aqueous solutions of tricalcium bismuth dicitrate are also unstable and form a sediment after several portions have been removed. Stable solutions can only be prepared with an excess ammonia solution, but as a result of the strong ammonia smell, these are not accepted by the patient. However, by spray drying, it is possible to obtain from such stabilized solutions a stable form of the colloidal tricalcium bismuth dicitrate complex, which can be used for producing solid medicaments, such as film or chewing tablets, or by redissolving or preparing liquid medicaments which can only be kept for a limited time, as described in German Patent 25 01 787.
In the case of the tricalcium bismuth dicitrate solutions filled into a medicine bottle, it is known that an ammonia excess must be present, but this can be calculated in such a way that the solution stability is not adversely effected by the ammonia loss which necessarily occurs when some of the solution is removed several times daily. However, this has the consequence of the solution smelling of ammonia and is unpopular with patients.
It has also been found that in the case of aqueous solutions it is necessary to add preservatives, so as to make the medicament sufficiently stable.
Another disadvantage of solutions supplied in medicine bottles is the lack of dosing accuracy, because generally no dosing aid, e.g. in the case of a measuring spoon is provided therewith, so that it is necessary to use tea or dessert spoons, which have widely differing dimensions.
In the case of tablets as well, the dosing accuracy of the single or multiple dose is unsatisfactory, because it varies as a function of the degree of homogeneity of the material compressed and the tablet weight.
Another disadvantage of chewing tablets is their long contact with the oral mucosa and the dark coloring caused to the tongue and dental enamel. In addition, the active substance must first dissolve in the saliva or gastric juice in order to enable it to reach the action point of the gastric mucosa. As the active substance can only dissolve after release from the tablet or from the tablet particles formed during chewing, it is frequently locally available in different concentrations. As the solubility of the active substance is also pH-dependent and the pH-conditions in the stomach are subject to intra-individual and inter-individual fluctuations, the active substance released from solid products and therefore the action thereof is not reproducible. It is also pointed out that it is also recommended, in the case of tablets, to subsequently drink liquid, so as to free the oral region from chewing tablet residues. It is clear that such tablets only have limited acceptance by dental prosthesis wearers.
An object of the present invention is to avoid the aforementioned disadvantages of the prior art and to improve the aforementioned medicinal product so that it is more patient-friendly.
The invention is consequently directed at a product which is not only the medically most appropriate application or administration, but which is simultaneously neutral as regards taste and odor and which has a high dosing accuracy with regard to the single and multiple dose. It is clear that the sought medicinal product must also be simple and inexpensive to manufacture and have a good storage stability.
This problem is solved by the improved medicinal product and production process of this invention.